Cleared Traditional

K915761 - BIVONA-COLORADO VOICE PROSTHESIS (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915761 · Bivona Medical Technologies · Ear, Nose, Throat device
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Jun 1992
Decision
188d
Days
Class 2
Risk

K915761 is an FDA 510(k) clearance for the BIVONA-COLORADO VOICE PROSTHESIS. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on June 29, 1992 after a review of 188 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3730 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K915761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date June 29, 1992
Days to Decision 188 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 89d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EWL Prosthesis, Laryngeal (taub)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.